SAN DIEGO, CA, USA I March 20, 2023 I Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology, announced today that the first patient has been dosed in the phase 1 clinical study (NCT05482893) of PT886, a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47 for the treatment of gastric, gastroesophageal junction and pancreatic adenocarcinomas. PT886 was assembled using Phanes’ proprietary bispecific antibody platforms PACbody™ and SPECpair™ and was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA last year.

PT886 directly kills tumor cells via both the ADCP activity of macrophages and ADCC activity of NK cells, and by targeting both claudin 18.2 and CD47 overexpressed on the surface of tumor cells, it broadens the tumor killing spectrum. Additionally, PT886 is expected to induce the presentation of tumor neoantigens by channeling tumor cells into phagocytotic antigen presenting cells (APCs) and stimulate adaptive immune system by indirectly activating T cell killing of claudin 18.2 low or negative tumor cells through recognition of tumor neoantigens. The anti-CD47 arm of PT886 is highly differentiated and has demonstrated minimum binding to human red blood cells while maintains strong binding activity to CD47 on tumor cells. “PT886 targets a validated tumor associated antigen in claudin 18.2 with enhanced anti-tumor activity and broadened tumor killing spectrum through a best-in-class anti-CD47 arm. It is a product of Phanes’ ingenious innovation in creative design of both novel therapeutic approaches and practical technologies,” said Dr. Ming Wang, Founder and CEO of Phanes Therapeutics.

The multi-center Phase I clinical trial of PT886 is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric, gastroesophageal junction and pancreatic cancers that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate.  Enrollment in the trial is open to individuals aged 18 years and older who have measurable disease with at least 1 lesion amenable to response assessment per RECIST 1.1 criteria, adequate organ function, and an ECOG performance status of 0 to 1.

For more information on the study please visit (NCT05482893).

About Phanes Therapeutics

Phanes Therapeutics, Inc. is a clinical stage biotech company focused on innovative drug discovery and development in oncology. Currently, it has three assets at clinical stage, including its best-in-class monoclonal antibody (mAb) program, PT199, and two first-in-class bispecific antibody programs, PT886 and PT217. Both PT886 and PT217 have been granted orphan drug designation by FDA. Its pipeline also includes humanized mAbs, biparatopics, and single-chain variable fragments (scFvs) against multiple tumor-associated antigens (TAAs) that are suitable for ADC and CAR-T applications, respectively.

The company has built a strong pipeline by leveraging its proprietary technology platforms: PACbody™, SPECpair™ and ATACCbody™ to develop novel biologics that address high unmet medical needs in cancer. PACbody™, is a proprietary approach for constructing bispecific antibodies without using protein engineering so that the antibody molecules maintain native structures with superb CMC characteristics. SPECpair™ allows mAb-like manufacturability of bispecific antibodies with native IgG-like structures, and ATACCbody™ is a technology for targeting solid tumors using immuno-oncology molecules with modulated activities designed to minimize the risk of cytokine release syndrome.

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SOURCE: Phanes Therapeutics